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MDCPSS Newsletter, Winter/Spring 2017
Treasury Update
Membership Updates
2017 SOT Annual Meeting
Medical Device Standards
MDCPSS Webinars
Dear Members,
Hello and welcome to the Medical Device and CombinationProduct Specialty Section’s (MDCPSS) spring newsletter.
This past year has been busy and productive. Our Vice PresidentBarb Henry has served on virtually every committee and kept usmoving forward, our website liaison, Vice PresidentElect TaylorBuilee, has done a great job of ensuring that our website is up todate and populated with useful information, Secretary/TreasurerShawn Deng has skillfully coordinated our webinar program,Councilor Sherry Parker has been the expert editor of the specialtysection’s newsletter, which is our main communication vehicle,while Councilor Whitney Christian has provided key support for thewebinar program and contributed timely articles to the newsletter,plus our Graduate Student Representative Daniel Lou andPostdoctoral Representative Monica Pombo have served as ableambassadors to their organizations.
Webinars: So far this year we’ve sponsored three noteworthywebinars that were all thought provoking and well received.Additional details are provided in this newsletter. If you missedthem recordings are available on the MDCPSS website.
On April 10th our last webinar of the year will be cosponsored bythe In Vitro and Alternative Methods (IVAM) Specialty Section andfeature two presentations:
• “ISO 109931 Biological Evaluation – the Risk Management ofUnstudied Extractables and Leachables (E&L) Impurities inMedical Devices and Combination Products” presented by Kim Li,Amgen, Inc.
• “AnimalSpecific Modeling for the 3Rs in PreclinicalAssessment: A Bone Drugs Example” presented by MarcoViceconti, University of Sheffield.
Mark your calendars so you don’t miss it!
SOT Meeting Events: This newsletter also provides a list of theMDCPSS’s SOT Annual Meeting events.
Membership: In December our headcount reached 170members, which is a record. This specialty section began in 2010with 51 members, and we’ve grown steadily ever since. For thoseof you that haven’t done so please renew your SOT membershipsoon and don’t forget to rejoin the MDCPSS!
Executive Committee: During the recent election there were twoopenings on the MDCPSS Executive Committee. To fill thosepositions I would like to welcome our newly elected officers SherryParker (Vice PresidentElect) and Megan Hahn (Councilor).
I also wish to thank the following individuals whose terms end inApril: Alan Hood (Past President), Sherry Parker (Councilor), andMonica Pombo (Postdoctoral Representative). We’re verygrateful for the terrific job they all did! Please continue to check theMDCPSS website for additional information and updates on ouractivities. Also, don’t hesitate to contact me or any other ExecutiveCommittee members with ideas, feedback, and suggestions.
We hope to see you at the MDCPSS Reception and Postersession during the SOT Annual Meeting.
It’s been an honor to serve as your 201617 MDCPSS President.
Sincerely,
Kelly Coleman
MDCPSS President
MDCPSS WINTER/SPRING NEWSLETTER
Volume 8Issue 1
Table of Contents (click to move directly to page)
2
4
7
5
President’s Message
EU/MDR Updates 8
Upcoming Events 9
6 MDCPSS Mission 10
MDCPSS Newsletter, Winter/Spring 2017 Page 2
OFFICERS
(20162017)Click on names
PresidentKelly Coleman
Vice PresidentBarbara Henry
Past PresidentAlan Hood
Vice PresidentElectTaylor Builee
Secretary/TreasurerShawn Deng
CouncilorsSherry ParkerWhitney Christian
Student RepresentativeDaniel Luo
Postdoctoral RepMonica Pombo
MDCPSS WebsiteMDCPSS EC
Newsletter EditorsSherry ParkerWhitney ChristianAlan HoodMDCPSS EC
MDCPSS Webinars
MDCPSS hosted a webinar entitled "Evaluation of Medical Devices for
Genetic Toxicity: A Global Perspective", held on October 1 9, 201 6.
Webinar speaker was Robert Przygoda, Johnson & Johnson.
Abstract: Genotoxicity is a key safety evaluation endpoint of healthcareproducts including pharmaceuticals and medical devices. It is also an everevolving area in terms of the advancement of science and regulation. TheISO 109933 standard governing genotoxocity testing for medical deviceswas recently updated in 2014. Furthermore, quite a few national regulatoryagencies have issued their own guidance to use the ISO 109933 standard,such as the recently published US FDA, Use of International Standard ISO109931, Biological evaluation of medical devices Part 1: Evaluation andtesting within a risk management.The presentation discussed the topics below:
• What is different about evaluating the genotoxicity of medical devices?
• How to determine if genetic toxicity evaluation is needed.
• ISO 109933 (2014)—Requirements (Risk Based Approach, ChemicalCharacterization, Tests, Test Sample Preparation, Reports)
• ISO TR 1099333 (2015)—Guidance on Tests to Evaluate GenotoxicitySupplement to ISO 109933.
• Challenges using ISO 109933 Globally accepted but subject tointerpretation by national regulatory agencies: US FDA guidance, Japanguidance and considerations for China submissions.
A recording of the webinar and a copy of the slides are available on theMDCPSS Website:http://www.toxicology.org/groups/ss/MDCPSS/pastevents.asp
MDCPSS hosted a webinar entitled "ISO 1 0993-4 Biological Evaluation of
Medical Devices: Selection of Tests for Interaction with Blood", held on
December 1 4, 201 6. Webinar speaker was Michael Wolf, Medtronic, Inc.
Abstract: For medical device companies with bloodcontacting products, theISO 109934 guidance document is important because it defines generalrequirements and considerations for evaluating interactions of concern betweenthe devices and blood. The document describes: (1) classification of bloodcontacting medical devices based upon intended use and duration of contact asdefined in ISO 109931, (2) fundamental principles and scientific bases behindvarious methods of evaluating interactions of devices with blood, and (3) astructured selection of tests for consideration based upon intended use andblood contact duration. In short, this standard is a guide for startup companies,established industry, and regulatory agencies to assess the apparent pre
MDCPSS Newsletter, Winter/Spring 2017 Page 3
MDCPSS Webinars (Continued)
clinical blood compatibility of candidate cardiovascular devices and materials intended for human bloodcontact applications.
The foundation of ISO 109934 has several sources. However, since its inception in 2002, thedocument has received only minor revision. Over the past several years the revision of this documenthas involved review of hundreds of comments from around the world, with the FDIS recommended forformal approval in 2016. Concisely, the new document provides a simplified process flow diagram forhigh level planning decisions, a reduced and simplified table of example devices vs. testing categoriesfor consideration, and a streamlined table of actual tests for consideration in each test category.
Importantly, the standard suggests more opportunities for meaningful in vitro testing to supplement orreplace certain animal testing. More emphasis is also placed on the importance of testing bloodcontacting devices for impact on thrombosis.abolites in groundwater, pharmaceuticals, herbalsubstances and preparations and genotoxic drug impurities.
A recording of the webinar and a copy of the slides are available on the MDCPSS Website:http://www.toxicology.org/groups/ss/MDCPSS/pastevents.asp
MDCPSS hosted a webinar entitled “Effects of Nanoscale Particles in the Brain”, held January
23, 201 7.
Webinar speaker was Allison Elder, Department of Environmental Medicine at the University ofRochester Medical Center
Abstract: It is well understood that exposure to particulate matter is causally associated with adversecardiopulmonary health effects that are related to the generation of inflammatory mediators,autonomic nervous system activation, and the delivery of particles or their constituents to targettissues (translocation). A growing body of work has explored the ability of inhaled particles – with afocus on nanoscale particles (<100 nm in diameter) – to also have adverse effects in the centralnervous system via similar mechanistic pathways. Studies with very poorlysoluble nanoscaleparticles demonstrated translocation to distal tissues like the brain and that smaller particlesaccumulate more efficiently than larger particles, albeit at a small fraction of applied dose. Exposuresvia other routes have also shown the accumulation in various tissues of nanoscale particles. Theconsequences of particle accumulation in the brain, such as inflammation or the induction orexacerbation of neurodegenerative processes, are also being explored in animal models. Usingpoorlysoluble nanoscale Mn oxide particles, for example, we found that markers of oxidative stressand inflammatory cell activation were elevated in the same regions of the brain where Mnaccumulated following wholebody inhalation exposure in rats. Using a mouse model of Alzheimer’sdisease (AD), it was also demonstrated that exposure led to persistent microglial and astrocyteactivation, elevations in amyloid β42 protein, and decreases in synaptophysin staining. Similarfindings have been reported in studies of the effects of other particle types like diesel exhaust. Takencollectively, the findings from these studies suggest that inhaled particles can be transported to thecentral nervous system and that they can elicit tissue responses that could contribute to theprogression of pathology in those regions where accumulation occurs.This webinar is available on the MDCPSS website:http://www.toxicology.org/groups/ss/MDCPSS/pastevents.asp
MDCPSS Newsletter, Winter/Spring 2017 Page 4
Medical Device Standards
Updates to Medical Device Standards
The technical committee for ISO 10993 Biological Evaluation of Medical Devices, TC 194, met inAnnapolis, Maryland, September 1823, 2016. Many of the standards are in a significant state ofrevision, including ISO 109931 (Evaluation and testing within a risk management process), ISO1099317 (Establishment of allowable limits for leachable substances), and ISO 1099318 (Chemicalcharacterization of materials). Because these standards are critical for risk assessment of medicaldevices, a requirement of the risk management process according to ISO 14971 (Medical devices —Application of risk management to medical devices), the working groups are working hard to alignthese documents. Soon to be finalized ISO 10993 standards that are in final draft international standard(FDIS) stage include ISO 109934 (Selection of tests for interactions with blood), and ISO 1099316(Toxicokinetic study design for degradation products and leachables). Coming updates to ISO 109934were presented in a webinar in December by Mike Wolfe, from Medtronic.
At the end of 2016, a new version of ISO 109936 (Tests for local effects after implantation) waspublished. This version replaces ISO 109936:2007, and provides recommendations for brainimplantation (in Annex D), more guidance throughout on implantation of absorbable materials, moredetailed examples of histopathological scoring, and long term implantation timepoint of 12 weeks waschanged to 13 weeks to be more consistent with the subchronic (90day)timepoint indicated in ISO 1099311 (Tests for systemic toxicity).
Other ongoing ISO 10993 projects include technical documents forthreshold of toxicological concern (TTC), and nanomaterials.
New Final Draft International Standards for biological evaluation of gas pathway devices
This year, four new standards for biological evaluation of gas path devices will be finalized:
• ISO 185621: Biocompatibility evaluation of breathing gas pathways in healthcare applications Part1: Evaluation and testing within a risk management process
• ISO 185622: Part 2: Tests for emissions of particulate matter
• ISO 185623: Part 3: Tests for emissions of volatile organic compounds (VOCs)
• ISO 185624: Part 4: Tests for leachables in condensate
Examples of breathing gas pathway devices include breathing systems and accessories, tracheostomytubes, ventilators, nebulizers, CPAP devices including masks. These standards were developed toaddress the risk of potentially hazardous substances being conveyed to the patient by the gas stream.They provide an overall strategy for evaluation of these devices (ISO 185621), including riskassessment, and specific testing considerations for particulates analysis (ISO 185622), analysis ofvolatile organic chemicals from the dry gas pathway (ISO 185623), and analysis of leachablechemicals in condensate (ISO 185624). The standard provides recommendations for biological testing,and TTC levels for limited, prolonged and permanent gas pathway devices, that are appropriate for riskassessment.
The coming update to ISO 109931 will include a reference to ISO 18562 for biological evaluation ofgas pathway devices. More information on available ISO 10993 and ISO 18562 standards can befound at ISO.org
MDCPSS Newsletter, Winter/Spring 2017 Page 5
201 7 SOT Annual Meeting
Monday, March 1 3, 201 7, 2:00-4:45 pm. Workshop, Modernizing Toxicological Risk Assessment forCompounds Released from Pharmaceutical, Consumer, Medical Device and Combination Products:Alternative Tools and Methods (CC Room 321; see below for details).Monday, March 1 3, 201 7, 5:00-6:00 pm. Hilton Baltimore Key Ballroom 5. Coffee Q&A MentoringEvent.Monday, March 1 3, 201 7, 6:00- 6:1 5 pm. Hilton Baltimore Key Ballroom 5. Subcommittee membersmeet and greet.Monday, March 1 3, 201 7, 6:00-7:30 pm. Hilton Baltimore KeyBallroom 5. Medical Device and Combination Product SpecialtySection Meeting/Reception.Tuesday, March 1 4, 201 7, 1 :1 5-4:30 pm. Poster Session,Medical Devices (P401P425).Tuesday, March 1 4, 201 7, 1:002:00 pm, Poster session tourmentoring event (P401P425).
Modernizing Toxicological Risk Assessment for Compounds Released from Pharmaceutical,
Consumer, Medical Device and Combination Products: Alternative Tools and Methods
Monday, March 1 3, 2:00 PM to 4:45 PM
Chairperson(s): Richard Hutchinson, Johnson & Johnson, Somerville, NJ; and Alan Hood, US
FDA, Silver Spring, MD. Endorser(s): In Vitro and Alternative Methods Specialty Section Medical
Device and Combination Product Specialty Section Regulatory and Safety Evaluation Specialty
Section
The potential toxicological effects of compounds released from medical devices and combinationproducts are a patient safety concern for both device manufacturers and regulatory stakeholders. Thissession will address the need to advance methods for the toxicological risk assessment of compoundsreleased from medical devices and combination products, and will explore opportunities formodernizing the risk assessment approaches for these compounds. This session is intended togenerate a dialogue for recent advancements from a variety of industry and nonindustry initiates in thedevelopment, acceptance, and application of alternative tools that complement or replace in vivotesting. The session focuses on two areas of toxicological risk assessment: hazard assessment, andrisk characterization. The session begins with modernizing hazard assessment through systematicreview using objective, reproducible methods that transparently document scientific judgments and thescientific basis of hazard identification conclusions. Then, recent insights on assigning Cramerclassification to compounds that can be used as guidance and improvement of in silico tools will be
MDCPSS Newsletter, Winter/Spring 2017 Page 6
Membership Update
Contributed by Daniel Luo:
The MDCPSS was formed in 2009 with 51 founding members. Since then we’ve grown steadily andnow have 170 members.
Our members come from industry, government, consulting and academia. From those who have indicatedtheir sectors, ~44% are in industry positions, ~15% are in consulting, ~10% are in academia, and ~10% are ingovernment related positions. Educational backgrounds range from BS degrees to those with MBAs, MPHs,PhDs, DVMs, and MDs.
presented. Computational tools, such as QSAR models and ReadAcross, to predict the toxicity ofcompounds lacking experimentallyderived toxicity data and the use of these predicted toxicity valueswill be discussed. The final topic is a semiquantitative risk evaluation matrix to determine the amountand rigor of component testing that may be necessary and appropriate to establish that the componentis suitable for its intended use. Academic/industry/consulting toxicological risk assessors and regulatoryaffairs representatives who have an interest in recent advancements in toxicological risk assessment inmedical devices, combination, and consumer products should consider attending this workshop.Introduction. Alan Hood, US FDA, Silver Spring, MD. Evaluation of the Potential ImmunotoxicityAssociated with Exposure to Perfluorooctanoic Acid (PFOA) with a Systematic Review Framework.Andrew Rooney, NIEHSNTP, Research Triangle Park, NC. A Practical Guidance for Cramer ClassDetermination. Jie Shen, Eli Lilly and Company, Indianapolis, IN. Modernizing Toxicological RiskAssessment for Medical Devices Using ISO 10993 Standards. Ron Brown, US FDA, Silver Spring, MD.Development and Justification of a Risk Evaluation Matrix to Guide Chemical Testing Necessary toSelect and Qualify Plastic Components Used in Production Systems for Medical Device andCombination Products. Dennis Jenke, Baxter International, Deerfield, IL.See more at: http://www.toxicology.org/events/am/AM2017/program.asp#SSMonday
201 7 SOT Annual Meeting (cont.)
MDCPSS Newsletter, Winter/Spring 2017 Page 7
Contributed by Dr. Shawn Deng:
MDCPSS had a successful year inmember registrations and net assets, withmodest expenses. Thanks to a strongyear of support from sponsors, MDCPSSnet assets maintained stable throughout the year. The MDCPSS Executive Committee thanks all this year'ssponsors for helping to make MDCPSS 2017 activities possible. Please consider making a tax deductibledonation of any amount to support MDCPSS.MDCPSS accepts donations by check or credit card. Checks may mailed to the following address:Medical Device and Combination Product Specialty Section, Society of Toxicology, 1821 MichaelFaraday Drive, Suite 300, Reston, VA 20190. Credit card donations may be completed by contactingRaul A. Suarez ([email protected]) at SOT Headquarters (703 4383115 x1461). All donationsshould include the following: donor’s name, contact information, donation amount, and paymentinformation.
Treasury Update
2016 Net Assets
Dec 2016 $24,532Nov 2016 $24,532Oct 2016 $24,432Sept 2016 $24,432Aug 2016 $24,432July 2016 $23,932
2016 MDCPSS Sponsors
Medtronic
Kelly Coleman
Ethicon
American Preclinical Services
WL Gore & Associates
WuXi AppTec
Membership Updates (Cont.)
2017 MDCPSS Sponsors (so far)
Medtronic
Edwards Lifesciences
MDCPSS Newsletter, Winter/Spring 2017 Page 8
EU/MDR Updates
The European Union Medical Devices Regulation: A Brief Overview
By Whitney V. ChristianOn February 22, 2017, the final version of the European Union (EU) Medical Devices Regulation (MDR)1 was
published. This legislation replaces the European Active Implantable Medical Devices Directive (AIMDD)2 and
the EU Medical Devices Directive (MDD)3, which were established in 1990 and 1993, respectively. The EU MDR
is a more restrictive regulatory framework that must be met to obtain a Conformité Européenne (CE) Mark for
medical device conformity and, in turn, approval for sale in the European Economic Area. Under prior regulatory
directives, the EU device market has long been an appealing first market destination due to a less restrictive
regulatory environment, which resulted in shorter market authorization timelines for medical devices. The EU
therefore served as an ideal place to test innovative medtech products in patients and develop a portfolio of
clinical data supporting safety, which could be used to obtain FDA approval later. With the implementation of the
EU MDR, it is anticipated that the EU will become a less attractive market because of the increased cost and
prolonged timetomarket associated with device registration, but for a good reason.
The full article which is available through a link on the MDCPSS website (see below) explains the implications of
the MDR, and provides some of the chapter highlights and major regulatory changes in the EU MDR with
specific examples. Major chaptors include the following:
Chapter I - Scope and definitions: Specific products without an intended medical purpose but with a risk
profile like medical devices (e.g., products for aesthetic purposes, such as contact lens, cosmetic augmentation
implants, liposuction equipment, and cosmetic lasers) are now regulated under the EU MDR (see Annex
XVI).The definitions of a medical device and an accessory have been expanded in the EU MDR, resulting in
products previously outside the scope of the EU MDD becoming accessories and products previously
considered accessories under the EU MDD becoming medical devices (see Article 2).
Chapter II - Making available on the market and putting into service of devices, obligations of economic
operators, reprocessing, CE marking, free movement: The EU MDR states that a device must meet the
general safety and performance requirements set out in Annex I. Per Annex I, devices, parts thereof, or materials
therein that contain more than 0.1% (w/w) substances which are carcinogenic, mutagenic, or toxic to
reproduction (CMRs) or substances having endocrine disrupting properties (identified in REACH) must be
labelled on the device itself and/or on the packaging with the list of such substances, and justification for their
presence must be provided. Per Article 17, reprocessing of singleuse devices is permitted in Member States
that allow it (i.e., local law may prohibit reprocessing). The reprocessor is considered the manufacturer of the
reprocessed device and assumes the obligations required of manufacturers, including product liability.
Chapter III - Identification and traceability of devices, registration of devices and of economic operators,
summary of safety and clinical performance, European database on medical devices: All medical devices
will require a unique device identification (UDI) code, which contains a device identifier (DI) and a production
identifier (PI), for the purposes of traceability (see Article 27).
Chapter IV - Notified bodies:Under the EU MDR, NBs function as the regulatory enforcement arm of the
Member States rather than an industry partner, as viewed under the EU MDD. However, under the required
criteria, a conformity assessment body must meet to become designated and notified to the European
Commission, thereby becoming a “notified” body (i.e., accredited), is considerably more rigorous and detailed
than under the EU MDD (see Article 36 and Annex VII).
Chapter V - Classification and conformity assessment:Classification of certain devices has changed (see
Chapter III of Annex VIII – 22 rules), and this may lead to recertification of a device at a higher risk class. A fairly
complex set of procedures for conformity assessment appear in the EU MDR. The extent of the conformity
MDCPSS Newsletter, Winter/Spring 2017 Page 9
assessment is based on the device classification with highrisk devices receiving more in depth assessments
based on quality management system assurance and assessment of the technical documentationthan lowerrisk devices (see Article 52 and Annexes IX, X, and XI). New general safety andperformance requirements (including expanded device information on labels and websites) as well asspecific structure and content (including postmarket surveillance) requirements for technicalfiles/documentation are provided (see Annexes I, II, and III). Overall, the data and format requirementsare much more extensive than those of the EU MDD, which could cost manufacturers more time andmoney in preparing dossiers that are clear, organized, and readily searchable for the stringent reviewthey will receive from NBs.Chapter VI - Clinical evaluation and clinical investigations: In a clinical evaluation (per Article 61and part A of Annex XIV), the manufacturer must provide clinical evidence to demonstrate compliancewith the relevant safety and performance requirements appropriate to the characteristics of the deviceand its intended purpose (i.e., establish and verify clinical performance, benefit, and safety) for newdevices and devices currently on the market, as there is no grandfathering (see Article 120).Chapter VII - Post-market surveillance, vigilance and market surveillance:Per the life cycleapproach of the EU MDR, several forms of postmarket surveillance will be implemented thatmanufacturers are required to continuously carry out, including a postmarket surveillance reports. Ofnote, the PMCF report and the summary of safety and clinical performance (see Article 32) for ClassIII and implantable devices is required to be updated at least annually and submitted by themanufacturer to a NB for validation; after validation, the NB will then upload the summary toEUDAMED. Reports of serious incidents and field safety corrective actions (see Article 87) as well asstatistically significant trends (see Article 88) are also required.Chapter VIII - Cooperation between Member States, Medical Device Coordination Group, expert
laboratories, expert panels and device registers: Considerable effort is made in the EU MDR toensure that the new regulations are uniformly applied across all Member States through variousmeans of cooperationChapter IX - Confidentiality, data protection, funding and penalties: All parties involved in theapplication of the EU MDR are mandated to respect the confidentiality of information and data that iscollected and shared (see Article 109), including personal data (see Article 110) as well ascommercially confidential information, trade secrets, and intellectual property (unless disclosure is inthe public interests). However, Article 1(16) supports freedom of information for the press and freedomof expression in the media, which potentially conflicts with the intention of protecting confidentialityand presents possible scenarios for misuse.Chapter X - Final provisions: Per Article 120, CE Mark certificates issued by NBs under theAIMDD/EU MDD prior to the date of entry into force for the EU MDR (i.e., the date the EU MDR ispublished in the Official Journal of the European Union, which is projected for May 2017) will remainvalid until the end of the period indicated on the certificate, with some exceptions.References
1.Council of the European Union, Regulation of the European Parliament and of the Council on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC and 93/42/EEC, 22 February 2017.
2.Council of the European Communities, Council Directive 90/385/EEC of 20 June 1990 on the approximation of
the laws of the Member States relating to active implantable medical devices, 20 June 1990.
3.Council of the European Communities, Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices, 14 June 1993.
EU/MDR Updates (continued)
MDCPSS Newsletter, Winter/Spring 2017 Page 10
MDCPSS Mission
The mission of the Medical Device and Combination Product Specialty Section is to:
• Provide an international focus group for toxicologists working in the area of medical devices andcombination products including a device component.
• Promote the development of new experimental methods for the evaluation of medical devices.
• Sponsor scientific and educational programs that emphasize current developments and issues in thetoxicological evaluation of medical devices.
• Promote proactive communication and interactions among toxicologists in government regulatoryagencies, regulated industry, and academia regarding current issues in medical device toxicology.
• Stimulate interest in medical device safety as a career path for new toxicologists.
Don't forget to visit the MDCPSS Website for regular updates:https://www.toxicology.org/groups/ss/MDCPSS/index.asp
Upcoming Events
Joint webinar with IVAM:
April 10, 2017. 11am EST.
PRESENTER 1: Kim Li, PhD, DABT, MPH, Amgen Inc. Thousand Oaks, CA
Title: ISO 109931 Biological Evaluation – the Risk Management of Unstudied Extractables andLeachables (E&L) Impurities in Medical Devices and Combination Products
PRESENTER 2: Marco Viceconti, Executive Director, Insigneo Institute for in silico Medicine, TheUniversity of Sheffield and Sheffield Teaching Hospital NHS Foundation Trust
Title: Animalspecific modelling for the 3Rs in preclinical assessment: a bone drugs example
See this link to register:https://aimhq.webex.com/aimhq/onstage/g.php?MTID=e037d459dcbf20aac3c525f46243d7e16
Please see the link to the complete article athttp://toxchange.toxicology.org/p/fo/st/thread=26086
